56-90326S

GUDID 07613327382426

1.2MM DYNAMIC MESH-MALL-LARGE-S

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable
Primary Device ID07613327382426
NIH Device Record Key9f08ebae-a5fa-4ca5-a227-72c476e84362
Commercial Distribution StatusIn Commercial Distribution
Version Model Number56-90326S
Catalog Number56-90326S
Company DUNS316153956
Company NameStryker Leibinger GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter
Device Size Text, specify0
Width120 Millimeter
Length120 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327382426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWOPlate, cranioplasty, preformed, alterable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-12-20
Device Publish Date2018-11-19

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

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07613327401738 - NA2025-01-17 SternalPlate, T
07613327634952 - NA2024-12-16 Drill for 6514-7-200 WL 16mm
07613327634969 - NA2024-12-16 Drill for 6514-7-200 WL 12mm
07613327634976 - NA2024-12-16 Drill for 6514-7-200 WL 10mm
07613327634983 - NA2024-12-16 Drill for 6514-7-200 WL 12mm

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